Regulatory & Scientific FAQs

What are biopesticides?
Biopesticides, which consist of biochemical and microbial pesticides, are products that are natural in origin, or functionally similar to naturally occurring ingredient, and are used to control, repel or mitigate pests primarily through non-toxic mechanisms. Microbial pesticides consist of microorganisms, such as a bacteria, fungi, viruses or protozoans, as the active ingredient. While microbial pesticides can control many different types of pests, each separate active ingredient is relatively specific for its target pest. Biochemicals are pesticidal substances that are naturally occurring (or synthetically derived equivalents), have a history of exposure to humans and the environment exhibiting minimal toxicity, and have a non-toxic mode of action. Biochemical pesticides include ingredients such as semiochemicals (insect pheromones and kariomones), natural plant and insect growth regulators, natural repellents and attractants, enzymes, and mineral substances. Plant-incorporated-protectants (PIPs), which are pesticidal substances that plants produce from genetic material that have been added to the plant, are also categorized as biopesticides.

What are some examples of recently developed biopesticides?
Baccillus spp.: Bacillus licheniformis, B. pumilus, and B. subtilis are naturally occurring soil bacteria with fungicidal properties that together have successfully been used as seed treatments or dressings, foliar application and soil-applied control of diseases in a variety of crops.

Trichoderma spp.: Trichoderma is a genus of fungi that helps to control plant disease by stimulating plant host defenses and growth, and, under certain conditions, parasitizing harmful fungi within the plant root zone.

Azadirachtin: Azadirachtin is an insect growth regulator derived from neem tree seeds. Known to affect some 200 species of insects, azadirachtin disrupts insect feeding and inhibits its ability to molt as it changes from the pupa to adult stage.

Dysphania ambrosioides: is an extract of the plant Dysphania ambrosioides (syn. Chenopodium ambrosioides) is used to control a number of sucking insect pests such as aphids, leafhoppers, whiteflies and mites in citrus, grapes, tree nuts and vegetables. This product breaks down the pest’s exoskeleton, which adversely affects its respiratory system and interrupts its ability to navigate (find food).

What kind of benefits do biopesticides offer?
Biopesticides offer numerous benefits, whether they are used alone, in an organic production program or in conjunction with a synthetic chemical program. Biopesticides are often included in synthetic production programs as a mechanism to significantly improve the quality and yield of crops under challenging conditions. Biopesticides can be used to provide additional crop protection from pathogens, insect pests and weeds. When used alongside conventional pesticides, biopesticides can offer enhanced control over the elimination of target pests. For organic production systems, biopesticides represent some of the most significant crop protection tools that a grower has to produce a quality crop. Because of the standards placed on organic crop production, biopesticides are a key factor in maintaining healthy, bountiful crop yields. In addition, biopesticides classified as plant growth regulators enable growers to improve crop quality and yield through physiological benefits rather than pest control. The benefits provided by plant growth regulators include increased fruit size or enhanced color, which typically plays a critical role in crop price.

Biopesticides also offer increased options for pest control while limiting chemical use and promoting a more environmentally friendly image. Biopesticides typically target specific pests without disrupting the beneficial components of an agroecosystem. For example, most bioinsecticides only eliminate target pests while leaving beneficial insects alive. However, there are also other biopesticides, particularly those used for disease management, that tend to be more broad spectrum, which is useful for managing multiple pathogens that challenge the growth of a crop. In addition, biopesticides offer effective pest control and plant growth solutions while limiting the impact on the environment. Biopesticides have very limited toxicity to birds, fish, bees and other wildlife, and they help maintain beneficial insect populations, break down quickly in the environment, and can reduce the use of conventional pesticides applications.

What does the biopesticide market look like today?
In the late 20th century, as the high costs of synthetic chemicals became more evident, there was a resurgence in academic and industrial research related to biopesticide development. Coupled with the rapid expansion of organic agriculture in the last decade, biopesticide product development and adoption rates have grown substantially since the mid-1990s. Perhaps the single most important factor in recent market growth can be contributed to advancements in biopesticide technology. Significant research has resulted in product enhancements, including more effective formulation techniques, the ability to manufacture through mass production, increased storage and shelf-life capabilities, and improved application methods. Furthermore, a better understanding of biopesticides among end users has helped increase product adoption and market growth rate. In 2006, Arysta LifeScience estimated the global biopesticide market at $541 million. In 2008, a study released by Global Industry Analysts, Inc. estimated that biopesticides represented 3% ($750 million) of the overall pesticide market and would reach $1 billion by 2010. In research conducted by CPL Business Consultants (CPL), a UK consultancy, they estimate the North American biopesticide market at $497.3 million in 2010, which represents a 25.7% increase from 2008. In Europe, CPL estimates the biopesticide market at $541.4 million in 2011, with an estimated compound annual growth rate of 16.9% over the period 2000-2011.

How can TSG help me?

TSG Qualifications

TSG is a leading regulatory compliance consultancy that provides a unique blend of scientific and regulatory expertise to ensure the approval, and ongoing compliance, of chemically related products. At our core, we specialize in providing the regulatory and scientific support necessary to register pesticide products at the state (U.S. state, EU member state and Canadian provinces), federal and international level.

Our regulatory experts have substantial experience working with new active ingredients, inert ingredients, major new uses and new formulations, and routinely submit applications for biopesticides, including microbial pesticides and biochemical pesticides. TSG’s regulatory experts have strong working relationships with government officials, which help promote quick, effective and reliable service throughout the registration process. Working in conjunction with our scientific staff, TSG’s regulatory consultants ensure that all biopesticide application requirements are fully addressed to the satisfaction of regulatory authorities.

TSG’s toxicologists are highly skilled in the design, evaluation and interpretation of all toxicological studies, including acute, subchronic and chronic toxicity, developmental and reproductive toxicity, neurotoxicity and oncogenicity, mobility and environmental fate. Our toxicologists are also experienced in conducting environmental and human health assessments, including worker exposure, dietary and non-dietary risk assessment.

TSG’s chemists are familiar with the registration process for biopesticides and have extensive experience in satisfying the full scope of EPA’s requirements in the areas of product chemistry and composition, and manufacturing, including the necessary analytical methods. In addition, TSG’s chemists have extensive background in the design, implementation and presentation of environmental fate and residue studies needed to support biopesticides, such as metabolism in animals and soil, dissipation in foliage and soil, and residues in soil, crops and processed crop commodities.

Biopesticide Services

TSG’s team of regulatory and scientific experts have been involved with biopesticides since the beginning, and our strong international expertise in this area can provide a unique advantage to companies that are looking to develop a biopesticide market entry/expansion strategy, register new products, or maintain compliance in a constantly growing and changing regulatory environment. For companies that are manufacturing or sourcing material from China, TSG can provide valuable services such as finding bonafide Chinese suppliers, performing manufacturing audits, assisting with U.S. import issues, contract language and general communication between companies, and ensuring GLP compliance in China.

TSG’s biopesticide services include:

    EPA registration

    State registration

     The preliminary negotiation of data requirements,

    Designing and monitoring regulatory studies

    Preparing risk assessments

    Developing product labels

    Assembling applications

We have significant experience in:

    Product development

    Data development

    Data compensation

    Good Laboratory Practice (GLP) compliance

    Product chemistry

    Residue analysis

    The interpretation of data results

We also assist in the preparation of:

    Data waiver rationales

    Human health risk assessments

    Environmental risk assessments

    Tolerance petitions

    Label amendments

    New inert ingredient petitions

Contact TSG to learn how we can help.

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